WO2007027506A2 - Capteur de pression transseptale - Google Patents

Capteur de pression transseptale Download PDF

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Publication number
WO2007027506A2
WO2007027506A2 PCT/US2006/033108 US2006033108W WO2007027506A2 WO 2007027506 A2 WO2007027506 A2 WO 2007027506A2 US 2006033108 W US2006033108 W US 2006033108W WO 2007027506 A2 WO2007027506 A2 WO 2007027506A2
Authority
WO
WIPO (PCT)
Prior art keywords
anchor
imd
assembly housing
pressure sensor
electrode
Prior art date
Application number
PCT/US2006/033108
Other languages
English (en)
Other versions
WO2007027506A3 (fr
Inventor
Todd M. Zielinski
Douglas A. Hettrick
Original Assignee
Medtronic, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic, Inc. filed Critical Medtronic, Inc.
Publication of WO2007027506A2 publication Critical patent/WO2007027506A2/fr
Publication of WO2007027506A3 publication Critical patent/WO2007027506A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/29—Invasive for permanent or long-term implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/6882—Anchoring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • A61N1/0573—Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension

Definitions

  • the present invention relates to implantable medical devices. More specifically, the present invention relates to implantable medical devices that sense or measure pressure.
  • IMDs implantable medical devices
  • IPG implantable pulse generators
  • ICD implantable cardioverter/defibrillators
  • ICD implantable cardioverter/defibrillators
  • IMDs include both pacing and cardioversion/defibrillation capabilities.
  • a housing containing the pulse generator, battery, capacitors, processor, memory, circuitry, etc. is implanted subcutaneously.
  • One or more leads are delivered transvenously such that electrodes forming a portion of the lead are disposed within or contacting an outer portion of the heart.
  • the housing, or “can”, may also include one or more electrodes that are selectively used in combination with the various lead electrodes.
  • the leads sense electrical activity of the heart, typically represented as an electrogram (EGM), which is indicative of the cardiac depolarization waveform and indicates the timing of the various components of the complex.
  • EGM electrogram
  • This data indicates whether and when intrinsic events occur, their duration and morphology.
  • the timing of certain events is used to trigger various device actions. For example, sensing an atrial depolarization may begin a timer (an escape interval) that leads to a ventricular pacing pulse upon expiration. In this manner, the ventricular pacing pulse is coordinated with respect to the atrial event.
  • the heart includes four chambers; specifically a right and a left atrium and a right and left ventricle. Leads are commonly and routinely placed into the right atrium as well as the right ventricle.
  • the lead is typical guided through the coronary sinus and into a cardiac vein.
  • One or more electrodes are then positioned (within the vein) to contact an outer wall of the left atrium and/or left ventricle. While direct access to the interior of the left atrium and left ventricle is possible, it has been historically less preferable. As the left ventricle provides oxygenated blood throughout the body, a foreign object disposed on the left side and providing a sufficient obstruction could lead to the formation of clots and would increase the risk that such a clot would form and be dispersed.
  • the sensing and utilization of electrical data is commonly employed as the electrodes used for delivering stimulus are typically also useful in sensing this data. This is generally non-problematic in left-sided applications as the electrical waveform is adequately sensed from the above described left side lead placement position.
  • a wide variety of other sensors are employed to sense parameters in and around the heart. For example, flow rates, oxygenation, temperature and pressure are examples of parameters that provide useful data in certain applications. Obtaining such data on the right side is typically non-problematic; however, obtaining the same data directly from the left side is made more difficult by the above noted desire to minimize invasiveness into the left atrium or ventricle.
  • Pressure data is a useful parameter in determining the presence, status and progression of heart failure.
  • Heart failure often leads to an enlargement of the heart, disproportionately affecting the left side.
  • Left side pressure values would be useful in monitoring the patient's condition; gauging the effectiveness of a given therapy such as Cardiac Resynchronization Therapy (CRT); and timing, controlling or modifying various therapies.
  • CRT Cardiac Resynchronization Therapy
  • Left atrial pressure is a variable that defines the status of heart failure in a patient. Attempts have been made to measure surrogates of this variable by monitoring pulmonary wedge pressure in clinical care. Measurement of ePAD with implantable devices such as the Medtronic ChronicleTM have been used to measure realtime intracardiac chamber pressure in the right ventricle and provide an estimate of mean left sided pressure. These techniques generally do not provide certain phasic information and do not necessarily correlate with left atrial pressures under certain conditions such as pulmonary hypertension or intense levels of exercise.
  • FIG. 1 illustrates an implantable medical device (IMD) having a plurality of leads implanted within a heart.
  • IMD implantable medical device
  • FIG. 6 is a schematic diagram of a plurality of anchor member and tine member.
  • FIG. 7 is a schematic diagram of a pressure sensor assembly positioned within a delivery catheter prior to implantation.
  • FIGS. 9-11 illustrate an alternative embodiment wherein an anchor nut secures the deployed position of the anchors.
  • FIG. 1 illustrates an implantable medical device (IMD) 10 that includes pacing, cardioversion and defibrillation capabilities.
  • IMD implantable medical device
  • a header block 12 forms a portion of the IMD 10 and three leads 14, 16, 18 are illustrated as coupled with the header block.
  • a right ventricular lead 14 is disposed in the right ventricle of the heart 20. More specifically, a helical electrode tip 24 is embedded into the apex of the right ventricle. The electrode tip 24 forms or is part of a tip electrode and a coil electrode 26 is also included. A ring electrode may be disposed between the tip electrode 24 and the coil electrode 26.
  • An atrial lead 16 is disposed within the right atrium such than an electrode 28 contacts an interior wall of the right atrium.
  • a left sided lead 18 is illustrated as passing through the coronary sinus 22 and into a cardiac vein. In this position, the left sided lead
  • the IMD 10 includes a housing that can act as an electrode or, though not illustrated, may include multiple electrodes. With such a configuration pacing stimuli is selectively delivered to the right atrium, the right ventricle, and/or the left ventricle. Likewise, a defibrillation pulse may be generated from any given electrode to any second electrode, such that the defibrillation waveform traverses the desired portion of the heart 20.
  • FIG. 2 is a simplified schematic diagram illustrating certain components of the IMD 10.
  • the IMD 10 includes a processor or CPU 1306, memory 1310, timing circuits 1314, timing output circuit 1304, pacing and defibrillation output circuits 1302, an appropriate lead interface 300, and appropriate electrode sensing circuits 1316.
  • the operation of the IMD 10 may be controlled by software or firmware and may be reprogrammed and/or provide data to an external device via telemetry unit 1318.
  • IMD 10 is illustrated in an exemplary manner and may or may not include all components illustrated and may include many additional components and capabilities without departing from the spirit and scope of the present invention.
  • FIG. 4 is a schematic diagram illustrating a pressure sensor assembly 115 in a deployed position.
  • a lead body 110 is deployed within the right atrium 30.
  • the pressure sensor assembly 115 is operatively coupled with the distal end of the lead body 110.
  • the proximal end of the lead body 110 will be coupled with the IMD 10 and though not illustrated, wires or other communication and/or therapy delivery mechanisms are disposed within the lead body 110.
  • Phasic information of the left atrial pressure provided by the pressure sensor 120 can be used, for example, by the IMD 10 to control several pacing parameters such as AV timing and VV timing for management of AF and CHF by optimizing left sided filling and ejection cycles and enhance cardiovascular hemodynamic performance. Such data may also be used for assessment of mitral regurgitation and stenosis. For device based management of atrial fibrillation, the phasic information can be used for discriminating atrial fibrillation from flutter and optimizing atrial anti-tachycardia pacing therapies.
  • Pressure sensor 120 provides diagnostic data to clinicians and/or control device operation by automated feedback control. Direct, real-time left atrial pressure measurement may be utilized to provide diagnostic information for management of heart failure and in patients with pacemakers, to optimize pacing parameters to prevent its progression. In addition, pressure sensor 120 provides information about the atrial substrate for management of AF and may control pacing parameters to prevent progression of AF. Reference is made to US Patent Application Serial Number 11/097,408, filed on March 31, 2005 and titled "System and Method for Controlling
  • the pressure sensor assembly 115 passes through an opening in the septal wall 100. This may occur at the fossa ovalis 36, where the septal wall is relatively thin; though this location is not mandated for the present invention.
  • the pressure sensor assembly 115 is held in place by anchors 130 disposed on one side of the septal wall 100 acting in opposition to tines 140 acting on the other side of the septal wall 100.
  • the anchors 130 and tines 140 "sandwich" the septal wall 100 between them. While various embodiments are illustrated representing anchor and tine combinations, it should be readily apparent that numerous variations exist that are within the scope of the present invention.
  • the pressure sensor assembly 115 may include one or more electrodes to deliver electrical stimulation and/or sense electrical activity.
  • a proximal electrode 160 is illustrated in a proximal portion of the pressure sensor assembly 115 and is not in contact with tissue. As such, it may function in a manner similar to a ring electrode. The proximal electrode 160 may be used, for example, to provide EGM data.
  • the anchors 130 may be electrically conductive or include portions that are electrically conductive such that the anchors 130 function as either a single collective electrode or individual independent electrodes. As illustrated, the anchor base 155 provides a common electrical point to which the various anchors 130 are attached.
  • the anchors 130 may be used to provide electrical pacing stimuli and of course, sense electrical activity.
  • the location selected for placement of the pressure sensor 120 determines the proximity of the assembly 115 to conductive tissue.
  • the fossa ovalis 36 is typically non-conductive while the surrounding fossa limbus 38 is conductive.
  • the anchors 130 can be selected and adjusted to not only retain the assembly 115 in the proper position, but also to contact conductive tissue to act as a pacing electrode.
  • FIG. 5 schematically illustrates one anchor 130.
  • the anchor 130 includes a contact arm 170 coupled via a flex point 175 to a locking tip 180.
  • the locking tip 180 is inserted into the anchor base 155 and retained.
  • the contact arm 170 is able to pivot freely or with little resistance about the flex point 175.
  • the contact arm 170 has a strength, size and shape sufficient to abut cardiac tissue and retain the assembly in the selected position.
  • the control arm 170 may be made from a biocompatible electrically conductive material, a portion may be electrically conductive, or the entire arm may be non- conductive, thus providing only an anchoring function.
  • the tines 140 and tine support 142 are made from an appropriate biocompatible material that permits the tines 140 to fold towards the assembly 115 during implantation to extend to the position illustrated in FIG. 6 after piercing the septal wall 100.
  • the tines 140 and support 142 are made of silicone. The natural resiliency of the silicone causes the tines 140 to extend when permitted.
  • various metals or other materials may be employed that utilize resilient characteristics, shape memory, activated shape . memory (e.g., heat activated), or are mechanically deployed. Such deployment may occur by retracting (or effectively retracting by deployment of the anchors 130) the assembly 115 after piercing the septal wall 100. The wall 100 will contact the tines 140 and cause them to deploy.
  • the tines may be mechanically deployed from within the lead body 110 by, for example, guide wires, a stylet or the like.
  • the tines 140 are silicone and minimally obtrusive. Thus, their presence will have little impact on the left atrium and will likely lead to tissue encapsulation.
  • FIG. 7 is a schematic diagram of a pressure sensor assembly 115 positioned within a delivery catheter 200 prior to implantation.
  • the sleeve 150 is positioned proximally with respect to the anchors 130.
  • FIG. 8 schematically illustrates a sleeve deployment tool 220 in contact with the sleeve 150.
  • the assembly 115 has been advanced beyond the distal end of the delivery catheter 200 through distal opening 210.
  • the assembly 115 may be advanced to this position in any number of ways including using a stylet, simply advancing the lead body 100, or by using sleeve deployment tool 220 which essentially acts as an external stylet.
  • the sleeve deployment tool 220 is a tool operable from a proximal portion of the lead 110 that allows sufficient force to be exerted against sleeve 150 to cause sleeve 150 to advance.
  • the delivery catheter 200 is delivered to the target site and the distal opening is placed against the right atrial septal wall 100 where the pressure sensor 120 will pierce into the left atrium.
  • the assembly 115 is advanced distal to the delivery catheter 200 and the pressure sensor 120 (or a portion thereof) and the tines 140 pass into the left atrium.
  • the pressure sensor assembly 115 may include a piercing tip to facilitate puncturing the septal wall.
  • a piercing device e.g., an appropriate gauge needle, may be delivered via the delivery catheter 200 and caused to puncture the septal wall 100. The piercing device is retracted and the assembly 115 is delivered.
  • FIG. 8 illustrates a deployed device absent the septal wall 100.
  • the anchors 130 contact the tines 140.
  • the tines 140 are in contact with the septal wall 100 in the left atrium and the anchors 130 contact the septal wall 100 within the right atrium; more specifically, the electrically conducive fossa limbus (38) of the right atrium.
  • FIGS. 9 -11 illustrate an alternative embodiment wherein an anchor nut 240 is used instead of the sleeve 150.
  • an anchor nut deployment tool controlled from a proximal end of delivery catheter 200 is utilized to rotate the anchor nut 240.
  • the assembly 115 includes a threaded anchor base 230.
  • the anchor nut 240 is slid distally until reaching the threaded anchor base 230, then rotated to cause further distal movement.
  • the anchor nut 240 deploys the anchors 230 by pivoting them towards the septal wall (or distal from the catheter 200). It should be appreciated that by using either the anchor nut 240 or the anchor sleeve 150, the amount or degree to which the anchors 130 are pivoted is controllable. Thus, the tension imparted against the septal wall 100 is adjustable. Furthermore, the radial distance from the center of the puncture (e.g., center of pressure sensor 120) is also variable. That is, the anchor 130 will achieve its greatest radial distance when positioned orthogonally to the main axis of the sensor assembly 115. The more acute the angle between the anchor 130 and the assembly 115, the shorter the radial distance.
  • the center of the puncture e.g., center of pressure sensor 120
  • the anchor 130 is used as an electrode and needs to contact conducting cardiac tissue. If the sensor assembly 115 is deployed through conductive tissue, then there is likely no issue. Alternatively, if the sensor assembly 115 is deployed through non-conductive tissue (e.g., the fossa ovalis 36), then the anchors 130 need to extend to conducting tissue (e.g., the fossa limbus 38) to act as a pacing electrode.
  • conducting tissue e.g., the fossa limbus 38
  • the angle is adjusted to give an appropriate amount of tension as well as provide an appropriate radial distance so contact is made with conductive tissue. If this is insufficient, the puncture site may be selected (e.g., off center) so that at least one anchor 130 is capable of reaching conductive tissue. In addition, multiple sensor assemblies 115 may be provided that include anchors 130 having various lengths so that an appropriate assembly 115 is selected based upon a given patient's actual anatomy. Regardless of whether the puncture site is through conductive tissue, threshold testing is utilized to determine if the anchors 130 are properly positioned to act as pacing/sensing electrodes. If not, the position of the anchors 130 is adjusted until the threshold testing provides satisfactory results.
  • threshold testing is utilized to determine if the anchors 130 are properly positioned to act as pacing/sensing electrodes. If not, the position of the anchors 130 is adjusted until the threshold testing provides satisfactory results.
  • FIG. 11 illustrates an embodiment including a locking nut 260.
  • the deployment tool 250 is retracted.
  • the locking nut 260 is advanced over the lead 110 until reaching the threaded base 230.
  • the deployment tool 250 uses the deployment tool 250, the locking nut 260 is rotated until it firmly abuts the anchor nut 240. This prevents the anchor nut 240 from inadvertent reversal and movement of the anchors 130.
  • a number of embodiments have been shown and described.

Abstract

L'invention concerne un capteur de pression qui, dans un mode de réalisation, est passé à travers la paroi septale auriculaire. Des attaches pivotantes maintiennent le capteur de pression dans l'oreillette droite et des dents souples maintiennent le capteur de pression dans l'oreillette gauche. Le pivotement sélectif des attaches permet un ajustement radial de l'écartement radial des attaches, qui peuvent faire office d'électrode, de sorte à rendre le positionnement fonctionnel de l'électrode ajustable.
PCT/US2006/033108 2005-08-30 2006-08-23 Capteur de pression transseptale WO2007027506A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/215,679 2005-08-30
US11/215,679 US20070049980A1 (en) 2005-08-30 2005-08-30 Trans-septal pressure sensor

Publications (2)

Publication Number Publication Date
WO2007027506A2 true WO2007027506A2 (fr) 2007-03-08
WO2007027506A3 WO2007027506A3 (fr) 2007-05-10

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PCT/US2006/033108 WO2007027506A2 (fr) 2005-08-30 2006-08-23 Capteur de pression transseptale

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US (1) US20070049980A1 (fr)
WO (1) WO2007027506A2 (fr)

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